“National Research Council (US) Committee on Scientific Milestones for the Development of a Gene Sequence-Based Classification System for the Oversight of Select,” “A Proposal for Consideration: Sequence-Based Classification of Select Agents,” in Sequence-Based Classification of Select Agents: A Brighter Line, Washington (DC): National Academies Press (US), 2010.
Abstract (extract)
Early in our discussions, it became apparent that the criteria historically used to designate a pathogen as a Select Agent included characteristics that cannot be determined by sequence alone and therefore cannot be predicted with the degree of certainty required for regulatory purposes. We soon concluded that a sequence-based prediction system for oversight of Select Agents is not now possible, nor is it likely to be feasible in the foreseeable future. We did, however, recognize that a sequence-based classification system for Select Agents focused on consideration of sequences of concern could be developed and might help to clarify taxonomic distinctions among recognized Select Agents. By focusing on “sequences of concern” and coupling that with a cautionary alert (a “yellow flag system”), one might effectively address both biosecurity and biosafety goals. Near-term milestone and long-term research objectives were defined and are discussed in our report. Throughout our deliberations, we continually tried to balance the need for safety and security, while recognizing the challenges of potential dual-use applications that arise as the scientific community improves its understanding of the genomic basis that leads one organism to be pathogenic, while its near neighbor is not. We were also concerned about the potential burden that such an oversight program might have on the day-to-day conduct of science and the biotechnology business sector, and about the opportunities that might be missed. We concluded that a gene sequence-based classification system could be developed. We did not, however, address whether such as system should be developed or whether the additional administrative structure needed to maintain such a system would be justified. Therefore, we do not specifically recommend that either the classification or yellow flag system be implemented. Rather, we provide information about what is technologically feasible, and emphasize that the potential benefits of such a system should be considered and weighed against the cost and complexity of implementation.